The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

BAYSHORE MEDICAL CENTER

4000 SPENCER HWY PASADENA, TX 77504

June 10, 2016

VIOLATION:EMERGENCY SERVICES POLICIES

Tag No: A1104

Based on interview and record review, the facility failed to ensure the Emergency Department developed policies and procedures for the use of less restrictive measures in the medical care of patients. This failed practice resulted in patients being chemically restrained, temporarily paralyzed and placed on life support in the Emergency Department; 2 (Patient #1 and Patient #2) of 10 patients (Patient #1, #2, #3, #4, $5, #6, #7, #8. #9 and Patient #10) were intubated to control their behavior.

Findings included:

In a phone interview with MD #69 on 06/09/2016 at 0955, he stated, "General anesthesia and life support is being used at this hospital to control the behavior of psychiatric patients." He also stated, Patient #1 and Patient #2 had been intubated and placed on life support to control their behaviors.

In an interview with Chief Medical Officer (CMO) #72 on 06/08/2016 at 1045, he stated that MD #69 was very upset because Patient #1 and Patient #2 were intubated. He also stated that there was no protocol for the use of ketamine with psychiatric patients, restraints would have been a less restrictive measure to control behavior and the use of intubation should be a last resort.

In an interview with Behavioral Health Director MD #70 on 06/09/2016 at 1050, he stated:

Intubation of psychiatric patients for control of their behavior was not common practice in emergency departments.

He had seen psychiatric patients intubated in this facility ' s emergency department. The first line of treatment for agitated patients was psychiatric medications, "maybe 3-4 doses."

The use of restraints should have been a step between medications and intubation in the treatment of Patient #1 and Patient #2.

In an interview with Behavioral Health Educator RN #75 on 06/09/2016 at 0920, she stated that the facility intubated patients for behavioral problems "as a last resort." She also stated that she had never seen soft restraints at the facility.

In an interview with ED Director MD #76 on 06/09/2016 at 1245, he stated:

Restraints were not used for behavioral problems.

There was no protocol for the use of ketamine, intubation and ventilation for patients with behavior problems. "People are different."

The use of ketamine, intubation, and general anesthesia is a chemical restraint. "That's our goal."

In an interview with MD #56 on 06/09/2016 at 1300, he stated he was not aware of a set protocol for the use of ketamine, intubation and ventilation for the control of a psychiatric patient's behavior.

VIOLATION:PHARMACIST RESPONSIBILITIES

Tag No: A0492

Based on interview and record review, the facility failed to ensure the pharmacist provided oversight in the developing, supervising and coordinating protocols for and the use of medications in 2 (Patient #1 and Patient #2) of 10 patients (Patient #1, #2, #3, #4, $5, #6, #7, #8. #9 and Patient #10). This failed practice resulted in two patients being chemically restrained, temporarily paralyzed and placed on life support in the Emergency Department.

Findings included:

In a phone interview with MD #69 on 06/09/2016 at 0955, he stated, "General anesthesia and life support is being used at this hospital to control the behavior of psychiatric patients."

In an interview with Chief Medical Officer (CMO) #72 on 06/08/2016 at 1045, he stated MD #69 had voiced his concerns over the use of general anesthesia and life support to control the behavior of psychiatric patients.

In an interview with Pharmacy Manager #73 on 06/08/2016 at 1130, she stated, there was no protocol for sedating psychiatric patients with Ketamine and that she was not familiar with ketamine being used for behavioral problems. She stated she did not know patients were being intubated in the Emergency Department to control behavioral problems.

VIOLATION:GOVERNING BODY

Tag No: A0043

Based on observation, interview, and record review June 8-10, 2016, the governing body failed to ensure that:

1. The patient ' s right to receive care in a safe setting was upheld,

2. Protocols were developed in the Emergency Department for the progressive use of restraints, and

3. Pharmacy provided oversight for the use of chemical restraints in the Emergency Department.

The identified practices resulted in actual harm to 2 patients and presents a likelihood of harm to all current and potential patients with behavioral problems in the Emergency Department.

Based on interview and record review, the facility failed to ensure the patient's right to receive care in a safe setting as evidenced by the use of the most restrictive measures of restraint .prior to the use of less restrictive measures. This failed practice resulted in patients being chemically restrained, temporarily paralyzed, and placed on life support. This poses a risk for current and potential patients with behavioral problems in the Emergency Department. Refer to 482.13(c)(2) - [A-0144].

Based on interview and record review, the facility failed to ensure the patient or family was provided the opportunity to make an informed decision and provide consent regarding the use of chemical restraint. This failed practice resulted in the patient being chemically restrained, temporarily paralyzed and placed on life support without consent. This poses a risk for current and potential patients with behavioral problems in the Emergency Department. Refer to 482.13(b)(2) - [A-0131].

Based on interview and record review, the facility failed to ensure the pharmacist provided oversight in the developing, supervising and coordinating protocols for and the use of medications. This failed practice resulted in two patients being chemically restrained, temporarily paralyzed and placed on life support in the Emergency Department. This poses a risk for current and potential patients with behavioral problems in the Emergency Department. Refer to 482.25(a)(1) - [A-0492].

Based on interview and record review, the facility failed to ensure the Emergency Department developed policies and procedures in the medical care provided to behavioral patients. This failed practice resulted in two patients being chemically restrained, temporarily paralyzed and placed on life support in the Emergency Department. This poses a risk for current and potential patients with behavioral problems in the Emergency Department. Refer to 482.55(a)(3) - [A-1104].

VIOLATION:PATIENT RIGHTS

Tag No: A0115

Based on interview and record review on June 8-10, 2016, the facility failed to ensure that patient's rights were protected. Failure to do so resulted in actual harm to 2 patients and presents a likelihood of harm to all current and potential patients with behavioral problems in the Emergency Department.

Based on interview and record review, the facility failed to ensure the patient's right to receive care in a safe setting as evidenced by the use of the most restrictive measures of restraint prior to the use of less restrictive measures. This failed practice resulted in patients being chemically restrained, temporarily paralyzed and placed on life support . This poses a risk for current and potential patients with behavioral problems in the Emergency Department. Refer to 482.13(c)(2) - [A-0144].

Based on interview and record review, the facility failed to ensure the patient or family was provided the opportunity to make an informed decision and provide consent regarding the use of chemical restraint. This failed practice resulted in the patient being chemically restrained, temporarily paralyzed and placed on life support without consent. This poses a risk for current and potential patients with behavioral problems in the Emergency Department. Refer to 482.13(b)(2) - [A-0131].

The cumulative effect of the deficient practices were were determined to pose Immediate Jeopardy to patient health and safety, and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.

VIOLATION:PATIENT RIGHTS: INFORMED CONSENT

Tag No: A0131

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure 2 (Patient #1 and Patient #2) of 10 patients (Patient #1, #2, #3, #4, $5, #6, #7, #8. #9 and Patient #10) or family were provided the opportunity to make an informed decision and provide consent regarding the use of chemical restraint. This failed practice resulted in the patient being chemically restrained, temporarily paralyzed and placed on life support without consent.

Findings included:

In a phone interview with MD #69 on 06/09/2016 at 0955, he stated, Patient #1, a psychiatric patient, was given general anesthesia and placed on life support because of his behavior. He also stated Patient #1 was upset about being put on a ventilator and Patient #2, a "developmentally delayed" patient, was given general anesthesia and placed on life support "in order to control him."

Patient #1.

Record review of Emergency Notes by RN #58 dated 11/02/2015 at 1625 (the first of three admissions) revealed Patient #1 was discharged into the care of his sister. His mother's phone number was documented in the record.

Record review of Emergency Provider Report by MD # 57 dated 11/03/2015 at 1623 revealed the second of three admissions for Patient #1. He left prior to receiving his discharge paperwork.

Record review of Emergency Provider Report by MD #56 on 11/04/2015 (1139-1706) revealed the third of three admissions for Patient #1.

Record review of Emergency Notes by RN #63 on 11/05/2015 at 0117 revealed that Patient #1 was put into the seclusion room "due to increased agitation." While in seclusion, he punched the walls and door resulting in left hand lacerations. MD # 60 ordered the patient be moved from the psychiatric annex back to the emergency department.

Record review of Emergency Provider Report by MD #60 dated 11/05/2015 at 0235 revealed Patient #1 was intubated. At 0358, the lumbar puncture was done "emergently ... given patient not consentable [sic] as he is agitated, confused, no family contact."

Record review of Patient #1's chart November 4-12, 2015 did not reveal a consent for sedation.

Record review of Patient Notes by RN #78 dated 03/17/2016 at 1337 revealed Patient #2 stated he had used kush [synthetic cannabinoids] the previous day, "but difficult to tell how accurate patient is related to being medicated."

Record review of Patient Notes by RN #80 dated 03/18/2016 at 0920 revealed, Patient #2 stated he had been doing "Sonic Boom which is a synthetic marijuana." At 1120: "Management problem ... multiple intramuscular medications for agitation, threatening and combative behavior ... actively hallucinating." At 1333 - "Patient was put into seclusion ... Extremely poor boundaries." At 1437 - "While in seclusion patient began banging on the door so hard he broke the door ... code gray called. MD #76 notified and ordered that patient be transferred to ER to be intubated at 1437."

Record review of Patient Notes by RN #81 on 03/18/2016 (1442-1443) revealed, Patient #2 was given ketamine and intubated by MD #76.

Record review of Patient #2's chart did not reveal a consent for sedation.

Record review of History & Physical by MD #82 dated 03/18/2016 at 1658 revealed Patient #2 was a [AGE] year old African American male. He was placed in seclusion and "broke the door." "The patient was taken to the emergency room , sedated, paralyzed and intubated due to severe aggression. He is now on the ventilator ... sedated with diprivan. " Impression: Acute respiratory failure secondary to severe agitation.

Record review of Policy, Sedation Analgesia, dated 03/2015 revealed: "Statement of Purpose ... To ensure the following established goals are met: ... Assure the patient ' s safety and welfare ... The licensed independent practitioner or advanced practice professional is responsible for obtaining informed consent for the procedure ... Relative to the planned procedure and sedation analgesia, information is provided to the patient and family prior to administration regarding the following: ... Risk ... Potential benefits/drawbacks ... Any significant alternatives ... Potential problems related to recuperation ... "

Record review of Policy, Patient Rights and Responsibilities, dated 01/2012 revealed: "All patients are to be treated in a manner that preserves their dignity, autonomy, self-esteem, civil rights and involvement in their own care."

VIOLATION:PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No: A0144

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure the right for 2 (Patient #1 and Patient #2) of 10 patients (Patient #1, #2, #3, #4, $5, #6, #7, #8. #9 and Patient #10) to receive care in a safe setting as evidenced by the use of the most restrictive measures of restraint prior to the use of less restrictive measures such as physical restraints. This failed practice resulted in both patients being chemically restrained, temporarily paralyzed and placed on life support.

Findings included:

In a phone interview with MD #69 on 06/09/2016 at 0955, he stated:

"General anesthesia and life support is being used at this hospital to control the behavior of psychiatric patients."

There is controversy about the use of anesthesia and ventilators to control behavior but "some emergency room physicians feel it is appropriate."

Patient #1 was upset about being put on a ventilator.

Patient #2, a "developmentally delayed" patient, was given general anesthesia and placed on life support "in order to control him."

In an interview with Chief Medical Officer (CMO) #72 on 06/08/2016 at 1045, he stated:

MD #69 was very upset because Patient #1 and Patient #2 were intubated.

MD #69 was concerned over patient rights and wrote a letter about his concerns.

MD #69 brought up his concern about the use of ketamine on psychiatric patients in the emergency department in a meeting on May 31, 2016 with CMO #72, ER Director MD #76 and MD #91. The issue of patient rights was again discussed, along with airway safety and the need for better documentation.

The use of restraints would have been a less restrictive measure to control Patient #1.

The use of intubation should be a last resort.

In an interview with Behavioral Health Director MD #70 on 06/09/2016 at 1050, he stated:

Intubation of psychiatric patients for control of their behavior was not common practice in emergency departments.

He had seen psychiatric patients intubated in this facility's emergency department.

The first line of treatment for agitated patients was psychiatric medications, "maybe 3-4 doses."

The use of restraints should have been a step between medications and intubation in the treatment of Patient #1 and Patient #2.

Patient #1.

Record review of Emergency Notes by RN #58 dated 11/02/2015 at 1625 revealed the first of three admissions for Patient #1.

Record review of Emergency Provider Report by MD # 57 dated 11/03/2015 at 1623 revealed the second of three admissions for Patient #1.

Record review of Emergency Provider Report by MD #56 on 11/04/2015 (1139-1706) revealed the third of three admissions for Patient #1. He reported seizure, joint pain, depression, anxiety, auditory hallucinations and marijuana use. Inpatient treatment was recommended due to " bothersome hallucinations and acting odd. "

Record review of Emergency Notes by RN #63 on 11/05/2015 at 0117 revealed that Patient #1 was put into the seclusion room "due to increased agitation" where he punched the walls and door resulting in left hand lacerations. MD # 60 ordered the patient be moved from the psychiatric annex back to the emergency department.

Record review of the History & Physical by MD #68 dated 11/05/2015 at 1525 revealed Patient #1 "became very agitated" and was "intubated for further protection." Assessment included: altered mental status, acute respiratory failure, history of substance abuse, depression and acute psychosis.

Record review of Psychiatric Evaluation Note by MD #70 dated 11/09/2015 at 1536 revealed Patient #1 had a history of schizoaffective disorder.

In an interview with Behavioral Health Educator RN #75 on 06/09/2016 at 0920, she stated that the facility intubated for behavioral problems "as a last resort." She also stated that she had never seen soft restraints at the facility.

In an interview with ED Director MD #76 on 06/09/2016 at 1245, he stated:

Restraints were not used for behavioral problems.

The use of ketamine, intubation, and general anesthesia is a chemical restraint. "That's our goal."

In an interview with Behavioral Health Manager #77 on 06/09/2016 at 0920, he stated, that Corporate MD #89, was looking into how to handle behavioral problems of patients on kush [synthetic cannabinoids] that present to the ED.

Patient #2.

Record review of Emergency Provider Report by MD #76 dated 03/17/2016 at 0945 revealed, Patient #2 was a [AGE] year old aggressive, combative male brought in by the police in cuffs. Primary Impression: Agitation. Secondary Impression: Psychosis.

Record review of Patient Notes by RN #78 dated 03/17/2016 at 1337 revealed Patient #2 stated he had used kush [synthetic cannabinoids] the previous day, "but difficult to tell how accurate patient is related to being medicated."

Record review of Patient Notes by RN #80 dated 03/18/2016 at 0920 revealed Patient #2 stated he had been doing "Sonic Boom which is a synthetic marijuana." At 1120: "Management problem ... multiple intramuscular medications for agitation, threatening and combative behavior ... actively hallucinating." At 1333 - "Patient was put into seclusion ... Extremely poor boundaries. " At 1437 - " While in seclusion patient began banging on the door so hard he broke the door ... code gray called. MD #76 notified and ordered that patient be transferred to ER to be intubated at 1437."

Record review of Patient Notes by RN #81 on 03/18/2016 (1442-1443) revealed Patient #2 was given ketamine and intubated by MD #76.

Record review of History & Physical by MD #82 dated 03/18/2016 at 1658 revealed Patient #2 was a [AGE] year old African American male. He was placed in seclusion and "broke the door." "The patient was taken to the emergency room , sedated, paralyzed and intubated due to severe aggression. He is now on the ventilator ... sedated with diprivan." Impression: Acute respiratory failure secondary to severe agitation.

Record review of Policy, Sedation Analgesia, dated 03/2015 revealed: "Statement of Purpose ... To ensure the following established goals are met: ... Assure the patient ' s safety and welfare ... The licensed independent practitioner or advanced practice professional is responsible for obtaining informed consent for the procedure ... Relative to the planned procedure and sedation analgesia, information is provided to the patient and family prior to administration regarding the following: ... Risk ... Potential benefits/drawbacks ... Any significant alternatives ... Potential problems related to recuperation ... "

Record review of Policy, Patient Rights and Responsibilities, dated 01/2012 revealed: "All patients are to be treated in a manner that preserves their dignity, autonomy, self-esteem, civil rights and involvement in their own care."